BCI

GUDID 08426638163108

ICU MEDICAL, INC.

Pulse oximeter, line-powered
Primary Device ID08426638163108
NIH Device Record Keyc68d42a7-42f6-44f5-8d8b-aad82c9d0f26
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model Number6120A
Company DUNS118380146
Company NameICU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108426638163108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2025-04-16
Device Publish Date2016-11-16

On-Brand Devices [BCI]

1061058604068921-0470-0105-24
106105860383346120LA
106105860381439212A
1061058603809992M774325A
1061058603808292M774325
10610586037399920654335A
10610586037368920654235A
10610586037344920654230A
10610586037313920654220A
106105860368739004051
106105860368669004050
106105860368599004007
106105860368429004005
106105860368359004002
106105860368289004001
106105860368119004000
106105860367368400D
106105860366066004006
106105860365906004004
106105860365836004001
106105860365766004000
106105860365213304LS
106105860364159004003
106105860363789212S
084266381706876120N
084266381706636120SA
084266381706566120C
084266381706496120SC
084266381631086120A
250195170442466014
15019517043044WW3350
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.